ARIXTRA 1.5 mg (fondaparinux), anticoagulant

• ARIXTRA 1.5 mg/0.3 mL has marketing authorisation in adults in the prevention of venous thromboembolism:

 -  in major orthopaedic surgery of the lower limb (hip fracture, hip replacement, major knee surgery);

 -  in abdominal surgery, in patients considered at high risk for thromboembolic complications (abdominal surgery for cancer);

 -  in patients considered at high risk for venous thromboembolic complications and bedridden due to an acute medical condition (heart failure, acute respiratory failure, infectious or inflammatory disease);

 and in the treatment of symptomatic spontaneous acute superficial vein thrombosis of the lower limbs, with no associated deep vein thrombosis.

• This low dose has marketing authorisation as a dose adjustment of the 2.5 mg dosage only in patients with moderate to severe renal failure (CrCl between 20 and 50 mL/min).
• Given the lack of robust efficacy and safety data in case of renal failure, its role in the therapeutic strategy cannot be established.